Description

2-Hydroxy Atorvastatin Calcium Salt is a key pharmaceutical intermediate and impurity standard used in the development and quality control of statin-based cholesterol-lowering medications. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API), atorvastatin calcium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, regulatory compliance testing, and advanced chemical synthesis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC and LC-MS analysis in the quality control of Atorvastatin Calcium API and finished dosage forms.
• Process Development & Validation: Used in the research and development of synthetic pathways for atorvastatin, helping to optimize yield and minimize related substances.
• Regulatory Compliance & Documentation: Essential for preparing impurity profiles and method validation reports required by regulatory bodies like the FDA and EMA.
• Metabolite & Degradation Studies: Employed in stability testing and pharmacokinetic research to study the degradation pathways and metabolites of atorvastatin.
• Chemical Synthesis Intermediate: Acts as a building block in the advanced synthesis of atorvastatin and its structural analogs.
• Analytical Method Development: A critical component for developing and calibrating new chromatographic and spectroscopic analytical methods.

Basic Information

Product Name	2-Hydroxy Atorvastatin Calcium Salt
CAS No.	265989-46-6
Molecular Formula	C33H35FN2O6•1/2Ca
Molecular Weight	605.65 g/mol (for free acid, calcium salt form varies)
Synonyms	Atorvastatin 2-Hydroxy Impurity; Atorvastatin Impurity F (EP); 2-Hydroxy Atorvastatin; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt; Atorvastatin Related Compound F; 2-oxy Atorvastatin Calcium; Atorvastatin Hydroxy Impurity.
EINECS	Contact for details

Quality Control

Our 2-Hydroxy Atorvastatin Calcium Salt is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets high-purity standards suitable for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing purity, related substances, and residual solvents is provided with every shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Maximum Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.